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Progenics Pharmaceuticals, Inc.

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AZEDRA Topline Results Expected Between December 2016 and March 2017.
In late 2016 or early 2017, Progenics expects to report top-line results from its ongoing pivotal Phase 2b study of AZEDRA. If positive, the Company expects to submit an NDA to the FDA in 1H 2017.
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Source: press release, 3/11/16. http://ir.progenics.com/releasedetail.cfm?ReleaseID=960135

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December 3, 2015

Progenics Pharmaceuticals Achieves Target Enrollment in its Phase 2b Pivotal Trial of Azedra™

Evaluating the Ultra-Orphan Radiotherapeutic Candidate in Pheochromocytoma and Paraganglioma

TARRYTOWN, N.Y., Dec. 03, 2015 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that it has completed enrollment in its Phase 2b clinical trial of its ultra-orphan radiotherapeutic candidate Azedra™ for the treatment of malignant or recurrent pheochromocytoma and paraganglioma in accordance with the Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA). Progenics will allow enrollment to continue through the end of December so that patients already identified as potential candidates may have the opportunity to participate in the trial. The Company expects to report top-line data in the second half of 2016.

"Achieving the number of enrolled patients required under the SPA is a major milestone for Progenics and the Azedra program, a novel therapeutic candidate that has the potential to be the first approved therapy in the U.S. for the treatment of malignant or recurrent pheochromocytoma and paraganglioma," said Mark Baker, Chief Executive Officer of Progenics. "The trial, if positive, will provide the basis for a regulatory submission to the FDA, and we look forward to building on the impressive data reported to date as we advance Azedra as a treatment option for these very rare and life threatening tumors."

The open-label trial is designed to evaluate the efficacy and safety of the administration of two therapeutic doses of Azedra in patients with malignant relapsed/refractory pheochromocytoma or paraganglioma, ultra-orphan cancers with limited treatment options. The primary objective of the study is to determine the clinical benefit of Azedra based on the proportion of study participants with a reduction of all antihypertensive medication by at least 50% for at least six months. The SPA requires that 25% of 58 evaluable patients achieve the primary endpoint.

Azedra has received Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA.
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Source: press release, 12/03/15. http://ir.progenics.com/releasedetail.cfm?ReleaseID=945393

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Mark R. Baker, Chief Executive Officer, commented on the progress being made with the Azedra for pheochromocytoma phase-IIb program. He stated, "At the beginning of the year, we dosed the first patient in our relaunched pivotal phase-II trial of Azedra, our ultra-orphan product candidate for patients with malignant pheochromocytoma and paraganglioma. This study is being conducted under an SPA. The primary endpoint is a reduction in a patient's antihypertensive medication of at least 50% for 6 months. The requirements of the SPA will be met if at least 25% of 58 evaluable patients achieve this endpoint. The data today from this program has been quite impressive. We acquired it from Molecular Insight. They treated 41 patients before suspending enrollment due to lack of funding. 32% of those patients have achieved the primary endpoint, significantly de-risking this program. In addition, we have seen strong tumor response rates and survival data, providing additional evidence of clinical utility. We recently had the opportunity to share this data with KOLs in this space, who noted with great interest the improvement and survival among these patients. There currently aren't any approved therapeutic treatments which address the underlying cause of pheochromocytoma. And while our trial uses a surrogate end point, the response rates and survival data underscore the transformative potential of this candidate. We're pleased with how the trial is progressing and look forward to completing enrollment by year-end."
Source: Q1 2015 earnings conference call, 5/06/15.

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January 23, 2015
Progenics Pharmaceuticals Relaunches Pivotal Trial of AZEDRA(TM) in Pheochromocytoma
First Patient Dosed in the Resumed Study

Company Expects to Complete Enrollment by Year-End 2015

TARRYTOWN, N.Y., Jan. 23, 2015 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc., (Nasdaq:PGNX) announced today that it has dosed the first subject in the resumed pivotal Phase 2 clinical study of Azedra™ in patients with malignant pheochromocytoma and paraganglioma. The trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). Progenics acquired Azedra, a novel targeted cancer radiotherapy, in conjunction with its 2013 acquisition of Molecular Insight Pharmaceuticals (MIP).

"Relaunching this study is a very important milestone for patients with metastatic and/or recurrent pheochromocytoma/paraganglioma," said Dr. Daniel Pryma, Associate Professor of Radiology and Clinical Director of Nuclear Medicine and Molecular Imaging at the University of Pennsylvania, a current investigator and lead investigator on the original trial. "This treatment has been generally well tolerated and the data emerging from the trial to date has been encouraging. I am pleased to be resuming this study and feel that Azedra could represent the best treatment in malignant pheochromocytoma/paraganglioma in the future."

The study is designed to evaluate the efficacy and safety of the administration of two therapeutic doses of Azedra in patients with malignant relapsed/refractory pheochromocytoma or paraganglioma, ultra-orphan cancers with limited treatment options. The primary objective of the study is to determine the clinical benefit of Azedra based on the proportion of study participants with a reduction of all antihypertensive medication by at least 50% for at least six months. The SPA requires that 25% of 58 evaluable patients achieve the primary endpoint.

In late 2010, MIP suspended enrollment in the trial to seek additional funding. The trial has now resumed to fulfill enrollment requirements under the SPA. The trial has treated 41 patients and 32% of those patients have achieved the primary endpoint. The most common adverse events observed have been gastroenterological and hematologic disorders.

"As a targeted cancer treatment, Azedra has the potential to improve outcomes in patients suffering from pheochromocytoma and paraganglioma," stated Mark Baker, CEO of Progenics. "We are focused on successfully completing this pivotal trial and look forward to completing patient enrollment by the end of 2015, building on the promising data seen to date, and advancing this promising candidate toward the marketplace."

Azedra has received Orphan Drug and Fast Track designations from the FDA.
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Source: press release, 1/23/15. http://ir.progenics.com/releasedetail.cfm?ReleaseID=892628

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September 22, 2014
Progenics Pharmaceuticals Presents Long Term Follow-Up of Pivotal Phase 2 Trial of Azedra in Malignant Pheochromocytoma

TARRYTOWN, N.Y., Sept. 22, 2014 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today presented positive data from a pivotal phase 2 clinical study of Azedra™ in an oral presentation at the International Symposium of Pheochromocytoma and Paraganglioma (ISP) in Kyoto, Japan.

Azedra (Ultratrace™ Iobenguane I-131) is Progenics' radio-therapeutic candidate that targets the ultra-orphan diseases pheochromocytoma and paraganglioma. Progenics acquired the Azedra program in its 2013 acquisition of Molecular Insight Pharmaceuticals, which commenced the study, in which enrollment was suspended after accruing 41 patients.

Lead investigator Daniel Pryma, M.D., Associate Professor of Radiology and Clinical Director of Nuclear Medicine and Molecular Imaging, Department of Radiology at the University of Pennsylvania, presented long-term follow-up data on the 41 treated patients.

"These results suggest that treatment with Azedra has significant patient benefit both in symptom control as well as cancer control," said Dr. Pryma. "There are currently no approved anti-tumor therapies to treat these cancers. I am excited to continue this research and complete this study. Azedra appears to be a promising, well-tolerated agent for this disease."

As of June 2014, seven of the enrolled patients have received one and 34 have received two therapeutic doses of Azedra. The study's primary endpoint, a reduction of at least 50% of anti-hypertensive medications for at least six months, was achieved by 31.7% of patients. Patients receiving two therapeutic doses of Azedra had a median survival of 43.3 months as of June; long-term follow-up is continuing. The most common adverse events observed have been gastroenterological and hematologic disorders.

As previously announced, Progenics has established an agreement with Canada's Centre for Probe Development and Commercialization (CPDC) to manufacture Azedra. Progenics expects to resume the study in early 2015 with a total patient enrollment target of at least 58 evaluable patients.
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Source: press release, 9/22/14. http://ir.progenics.com/releasedetail.cfm?ReleaseID=871880

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November 25, 2013

Progenics Pharmaceuticals Relaunching Registrational Trial of Azedra to Treat Pheochromocytomas

To Resume Enrollment Under Special Protocol Assessment in Clinical Study of Novel Ultra-Orphan Therapy

TARRYTOWN, N.Y., Nov. 25, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that it is resuming a phase 2b clinical study of safety and efficacy of a novel targeted radiotherapy, Azedra™, in patients suffering from pheochromocytomas. Existing options for these rare endocrine tumors that form in the adrenal glands can fail to result in effective disease treatment.

Daniel Pryma, M.D., Assistant Professor of Radiology and Nuclear Medicine/Molecular Imaging Modality Chief of the Department of Radiology at the University of Pennsylvania Perelman School of Medicine, and lead investigator in the trial, said, "I have seen in my own research evidence that Azedra is a promising agent for the treatment of metastatic pheochromocytoma and paraganglioma — two orphan oncology indications with tragically unmet needs. There currently are no medications approved specifically to treat pheochromocytomas and paragangliomas."

Azedra originally was developed by Progenics' Molecular Insight Pharmaceuticals (MIP) subsidiary, which commenced the phase 2b study under a 2009 Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA). The compound also has Orphan Drug and Fast Track designations, which are intended to get important new therapies to patients sooner by expediting the review of drugs for serious conditions filling unmet medical needs. In late 2010 MIP suspended the trial, with enrollment two-thirds complete, to seek additional funding. Progenics, which acquired MIP in early 2013, plans for patient recruitment to continue after making drug supply manufacturing arrangements for the trial.

Following a successful completion of this phase 2b study, Progenics intends to submit a New Drug Application (NDA) and request priority review to receive FDA action on the application within six months instead of the standard ten.

Hagop Youssoufian, M.Sc., M.D., Executive Vice President of Research and Development for Progenics, said, "Azedra has the potential to be the first approved treatment for pheochromocytomas. Our team is energized by this opportunity to potentially bring a treatment option with improved dosing, safety and efficacy to patients suffering with these devastating conditions."
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Source: press release, 11/25/13. http://ir.progenics.com/releasedetail.cfm?ReleaseID=809272

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A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Estimated Enrollment: 75
Study Start Date: June 2009
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
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Source: Clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT00874614?term=azedra&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
AzedraOncologyPheochromocytomaRadiopharmaceutical agentTumor cells

Mechanism of action: Azedra is a molecular radiotherapeutic consisting of a metaiodobenzylguanidine (MIBG) molecule chemically bound to a radioactive iodine isotope (I-131) designed to deliver targeted radiation to a tumor site.

Phase of Development: IIb

Event Type: Data: Phase IIb trial results

Dates: 2016-12-01 - 2017-03-31

Results: Pending